FDA 510(k)

Solex 7 血管内热交换导管，ZOLL 启动套件

K号: K153226 · 2016-03-24

决定日期2016-03-24

产品代码NCX

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定Unknown

器械摘要

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit is the device name listed in this FDA 510(k) record. The listed applicant is Zoll Circulation, Inc.. It received FDA 510(k) clearance on 2016-03-24 under 510(k) number K153226. The device is classified under product code NCX. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

常见问题

What is the Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit?

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit is a medical device that received FDA 510(k) clearance on 2016-03-24. The listed applicant is Zoll Circulation, Inc.. The 510(k) number is K153226.

When did Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit receive FDA 510(k) clearance?

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit received FDA 510(k) clearance on 2016-03-24, under 510(k) number K153226.

Who is the listed applicant for Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit?

The FDA 510(k) record lists Zoll Circulation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit?

The FDA product code for Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit is NCX.

列明Zoll Circulation, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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相关器械（代码：NCX）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

官方来源

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